Data / Medical devices / Malaysia / Pleasure Latex Products Sdn. Bhd.
Pleasure Latex Products Sdn. Bhd.: FDA-registered device maker in JERAM Selangor, Malaysia, 9 510(k) clearances
Pleasure Latex Products Sdn. Bhd. is registered with the FDA (registration 9613994) in JERAM Selangor, Malaysia. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 11, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613994
- FEI number
- 3009084570
- Address
- Lot 5322, 15TH Miles Jalan Padang Gajah, JERAM Selangor, Malaysia, 45800
- Owner or operator
- PLEASURE LATEX PRODUCTS SDN. BHD. (9032729)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 13, 2007
- Registered through
- 2026
- Brand names listed
- CARE 38 ULTIMATE RIBBED, CARE 48 SPOTTED SENSATION, CARE 55 G-SPOT MINT, CARE XL VANILLA, Condom with Nonoxynol-9, Multiple Male Latex Condom, STIX Condoms, SURE Latex Ultrasonic Probe Cover and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Condom With Nonoxynol-9 | LTZ | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2003 | K022156 | LATEX ULTRASONIC PROBE COVER | ITX | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| June 23, 2003 | K023333 | MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| April 26, 2002 | K020272 | MALE LATEX CONDOM WITH RIBBED SURFACE | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| November 16, 2000 | K002571 | MULITPLE MALE LATX CONDOM | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| June 8, 2000 | K001377 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | LTZ | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| May 19, 2000 | K001221 | MALE LATEX COMDOM WITH DOTTED SURFACE | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| March 21, 2000 | K994312 | MALE LATEX CONDOM 56MM | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| March 21, 2000 | K994311 | MALE LATEX CONDOM WITH VANILLA FLAVOR | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
| February 26, 1999 | K982380 | SURE | HIS | Substantially Equivalent | Pleasure Latex Products Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Condom
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Condom With Nonoxynol-9
Updated September 11, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.